Cognitive Bias Modification for Interpretation Individuals With Chronic Musculoskeletal Pain

NCT06368362 | Completed

• 1 other identifier: CBM-I001
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Cognitive Bias Modification for Interpretation (CBM-I) trains participants to interpret ambiguous information as neutral or benign, rather than interpret it as being related to pain. The goal of this randomised controlled trial was to explore the feasibility and potential clinical benefits of CBM-I in people with chronic pain and also healthy, pain-free individuals.

Conditions

Chronic Pain; Musculoskeletal Pain Disorder

Keywords

Cognitive bias modification; Interpretation bias

Outcome Measures

Primary Outcomes (2)

• Emotional response to exercise induced pain

  Sensory and emotional pain words from the McGill Pain Questionnaire (MPQ) were presented, grouped as they are on the MPQ. Participants chose one word from each group most representing the pain experienced performing a dynamic arm exercise (rotating their arms in small circles forwards for 10 seconds then backwards for 10 seconds, repeating the process as many times as possible). Participants rated each word from 0 (not at all representative) to 10 (extremely representative) or indicated if none represented their exercise pain. Emotional response to exercise pain was calculated from intensity and representativeness scores. For intensity, words were assigned a numeric score according to MPQ instructions and summed for emotional and sensory words. For representativeness, mean rating of representativeness was calculated for sensory and emotional pain words. The sensory score was subtracted from the emotional score to compute emotional response to pain relative to the sensory experience.

  Immediately post-intervention

• Emotional response to pain-related images

  Participants were presented twenty pain-related images, and asked to rate the extent to which they felt negative emotions while viewing the image. After a fixation cross presented for 500 ms, a pain-related picture was presented for 6000 ms. This was followed by another cross presented for 500 ms then numbers from 0 (not at all negative) to 10 (very negative) was displayed. Participants were instructed to look at the picture on the screen then to rate their negative emotion from 0 (not at all negative) to 10 (very negative). The mean rating of emotional response to pain-related images was calculated for each participant.

  Immediately post-intervention

Secondary Outcomes (7)

• Fear of Pain

  Immediately post-intervention

• Anxiety

  Baseline

• Depression

  Baseline

• Emotional response to average clinical pain

  Immediately post-intervention

• Pain severity

  Baseline

Study Arms (4)

Benign CBM-I - Chronic pain

EXPERIMENTAL

Chronic pain participants randomised to receive benign CBM-I, which uses the Ambiguous Situations Task to train participants to neutral meanings of ambiguous scenarios.

Behavioral: Benign cognitive bias modification for interpretation

No CBM-I - Chronic pain

NO INTERVENTION

Chronic pain participants randomised to the 'no CBM-I' condition complete the Ambiguous Situations Task without any form of bias modification.

Benign CBM-I - Healthy

EXPERIMENTAL

Healthy participants randomised to receive benign CBM-I, which uses the Ambiguous Situations Task to train participants to neutral meanings of ambiguous scenarios.

Behavioral: Benign cognitive bias modification for interpretation

Pain-related CBM-I - Healthy

OTHER

Healthy participants randomised to receive pain-related CBM-I, which uses the Ambiguous Situations Task to train participants to painful meanings of ambiguous scenarios.

Behavioral: Pain-related cognitive bias modification for interpretation

Interventions

Benign cognitive bias modification for interpretation BEHAVIORAL

Benign cognitive Bias Modification for Interpretation (CBM-I) trains participants to interpret ambiguous information as neutral or benign rather than pain-related.

Benign CBM-I - Chronic pain; Benign CBM-I - Healthy

Pain-related cognitive bias modification for interpretation BEHAVIORAL

Pain-related cognitive Bias Modification for Interpretation (CBM-I) trains participants to interpret ambiguous information as pain-related.

Pain-related CBM-I - Healthy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Experience musculoskeletal pain (pain in muscles, bones, joints, tendons, or ligaments) that has lasted for at least the last 3 months before enrolment in the study
• Have visited a healthcare professional for their pain
• Aged 18-70 years
• Normal or corrected to normal vision

You may not qualify if:

• Any known reading difficulty
• Aged 18-70 years
• Normal or corrected to normal vision
• Experience frequent or continuous pain for the past three months before enrolment in the study
• Currently experiencing pain
• Any known reading difficulty

Sponsors & Collaborators

• University of Southampton: lead
• Economic and Social Research Council, United Kingdom: collaborator

Study Sites (1)

University of Southampton

Southampton, Hampshire, SO17 1BJ, United Kingdom

Location

MeSH Terms

Conditions

Chronic Pain; Collagen Diseases

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Daniel E Schoth, PhD

  University of Southampton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are not informed of the conditioned they are randomised to in this psychological intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two groups of participants (chronic musculoskeletal pain, healthy) were recruited, and within each group participants were randomised to one of two experimental conditions with a 1:1 allocation ratio with a parallel design. Participants with chronic musculoskeletal pain were randomised to benign CBM-I or no CBM-I, and healthy participants were randomised to benign CBM-I or pain-related CBM-I.

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 16, 2024
• Study Start: November 17, 2020
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Twelve months following publication of the results.
• Access Criteria: Email the study authors.

Locations

GB (1)